Pharmaco-Economic Study of Treatment Options in Patients With Advanced RCC

Completed

• Conditions: Renal Cell Carcinoma Metastatic; Renal Cell Carcinoma

• Registration Number: NCT03699579
• Lead Sponsor: Ipsen

Brief Summary

This is a retrospective cohort study aiming to collect data on patients' characteristics, resource utilization, adverse events management and calculate costs attributed to current treatments of advance RCC patients who have received at least one prior VEGF-targeted therapy in Taiwan from National Health Insurance (NHI) perspective.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-05
• Study First Submitted QC: 2018-10-05
• Study First Posted: 2018-10-09
• Study Start: 2019-02-22
• Primary Completion: 2019-06-23
• Study Completion: 2019-06-23
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-23
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Patients with confirmed diagnosis of clear-cell renal cell carcinoma
• Patients with evidence of metastatic disease
• Patients who have received at least one previous VEGFR-targeted therapy, i.e sunitinib, pazopanib or sorafenib
• Patients who received care at the selected medical centers, utilizing the National Health Insurance (NHI) reimbursed system at the time of the disease

Exclusion Criteria

• Patients enrolled in any clinical trial involving anti-cancer therapy
• Pregnant woman

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Medication usage	From start point for 2.5 months
Treatment's duration	From start point for 2.5 months

Secondary Outcome Measures

Name	Time	Method
Cost of medication used	From start point for 2.5 months
Costs of adverse event management	From start point for 2.5 months	(total calculated costs attributed to Adverse Effects (AEs) management according to the attached list of adverse events
Frequency of health resource usage	From start point for 2.5 months	Outpatient department visits, CT scan, blood test number and types
Cost of health resource usage	From start point for 2.5 months	Outpatient department visits, CT scan, blood test number and types

Trial Locations

Locations (2)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan